跳至主要内容
临床试验/NCT02170753
NCT02170753已完成不适用

Regional Manual Therapy and Motor Control Exercise for the Management of Chronic Low Back Pain With Hip and Spine Motion Loss: A Randomized Clinical Trial

University of Texas Southwestern Medical Center2 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2014年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
46
试验地点
2
主要终点
Change in Disability level

研究概览

简要总结

Purpose: The primary purpose of this study is to determine whether or not the addition of thoracic, pelvic, and hip manual therapy to a standard physical therapy (PT) approach consisting of motor control exercises and lumbar spine manual therapy is better than standard PT alone at improving thoracolumbar spine range of motion (ROM), hip ROM, pain intensity, disability level, and perceived change in patients with chronic low back pain (CLBP) and movement coordination impairments.

Hypothesis: In a CLBP subgroup with movement coordination impairments, participants receiving thoracic, pelvic, and hip manual therapy with standard PT will be superior to participants receiving standard PT alone at improving thoracolumbar spine ROM, hip ROM, pain intensity, physical disability level, and perceived change at two, four, and 12 weeks after initiating treatment.

详细描述

This study will use a 2x4 factorial mixed design with a between-factor independent variable (IV) of group and a within-factor IV of time. The dependent variables include hip ROM, segmental mobility of the thoracolumbar spine, pain, disability level, and patients' perceived rating of change (GROC). Hip ROM and spinal mobility variables will be measured by the researchers, while pain, disability level, and GROC score will be measured by self-reported questionnaires.

The experimental group will receive a motor control exercise program and manual therapy to the hips and spine corresponding to the individual's unique mobility impairments. The comparison group will receive a motor control exercise program and manual therapy to the lumbar spine only. Both groups will receive treatments at an outpatient clinic 2 times a week for 4 weeks. All outcome measures will be collected at baseline (except the GROC), and then at two weeks, four weeks, and twelve weeks after beginning treatment.

All study participants will receive a motor control exercise program consistent with standard of care. Exercises will be targeted to the abdominals, hip flexors, back extensors, hip extensors, hip flexors, hip abductors, and hip adductors, but will begin with those muscles that test weakest in the clinical exam. Generally, exercises for each subject begin with isolated isometric contractions to ensure adequate motor control, and progress through various degrees of agonist loading with co-contraction of synergists using isotonic open or closed chain movements. Instructions to gradually increase time under tension to a maximum of 30 seconds for four repetitions will be used in order to provide an element of graded-activity exposure and to reflect the tonic nature of stabilizing muscles. Participants unable to complete all exercises by the end of the fourth week will be instructed on how to progress to the final exercises with their independent home exercise program.

In addition to a motor control exercise program, all participants will receive manual therapy to the lumbar spine. Standard PT manual therapy will be limited to non-thrust passive accessory (PA) mobilizations from L1-L5 or soft tissue mobilization to the lumbar paraspinals or quadratus lumborum. Only the participants in the experimental group will receive manual therapy to the hips and thoracic spine according to the mobility impairments identified during the initial testing session. The manual therapy interventions utilized at the hips and thoracic spine are considered standard of care for treatment of those regions, but could be considered experimental for treatment of low back pain. Regional manual therapy will include a variety of thrust and non-thrust techniques targeting the thoracic, lumbopelvic, or hip joints. Hip-based techniques including anterior-posterior hip mobilization, caudal thrust or non-thrust mobilization, and posterior-to-anterior mobilization will be performed. The choice of initiating or suspending a specific manual therapy technique and the grade of treatment will be left to the discretion of the treating therapist (other than the PI). Prior to the commencement of the study, all treating physical therapists will be trained in administration of standard motor control exercises and manual therapy.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • between the ages of 18 and 65
  • have an active complaint of non-specific low back pain for at least three months
  • demonstrate hypomobility of the thoracic or lumbar regions on at least one spinal level
  • demonstrate at least two of the following unilateral or bilateral hip ROM deficits: hip flexion < 110°, hip extension loss > 6°, or hip rotation < 30° internally or externally
  • demonstrate any one of the following: pain that worsens with sustained end- range movements or positions, lumbar hypermobility, diminished trunk or pelvic muscle strength and endurance, or movement coordination impairments during community/work activities
  • Modified Oswestry Score ≥ 30%

排除标准

  • evidence of red flags, including fracture, infection, spinal tumor, or cauda equina syndrome
  • pain that can be centralized through repeated movements
  • signs of hyporeflexia, hypoesthesia, and myotomal weakness indicative of nerve root compression
  • pregnancy
  • systemic inflammatory conditions such as rheumatoid arthritis or ankylosing spondylitis
  • inability to safely tolerate manual therapy to the spine or hips
  • injections to the low back within the 2 weeks preceding the initial evaluation

结局指标

主要结局

Change in Disability level

时间窗: Baseline and 2 weeks, 4 weeks, and 12 weeks after beginning treatment

A subjective report of the participant's average level of perceived disability with functional tasks due to LBP as measured by the Modified Oswestry Low Back Pain Disability Questionnaire (ODQ).

次要结局

  • Change in Thoracolumbar spine range of motion(Baseline and 2 weeks, 4 weeks, and 12 weeks after beginning treatment)
  • Change in Hip range of motion(Baseline and 2 weeks, 4 weeks, and 12 weeks after beginning treatment)
  • Change in Pain intensity(Baseline and 2 weeks, 4 weeks, and 12 weeks after beginning treatment)
  • Change in Perceived change(2 weeks, 4 weeks, and 12 weeks after beginning treatment)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验